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| |  Roche Submits NDA for its AIDS Drug, Invirase NUTLEY, N.J., Sept. 5 1995 -- Hoffmann-La Roche Inc. announced today that it has submitted a New Drug Application (NDA) to the FDA for its AIDS drug Invirase(TM) (saquinavir). Invirase leads the development of the new and promising class of AIDS therapeutics called proteinase inhibitors. It works by blocking the HIV proteinase enzyme, which is critical to the replication of the AIDS virus. "Based on research we have conducted, we are confident that Invirase will become a valuable new tool for physicians who treat people with AIDS," said Juergen Drews, M.D., president of international research, Roche Group. "If progress is to be made in managing HIV disease, patients and their physicians need access to additional, novel therapeutics. Invirase is such a therapeutic." While the currently available treatments like HIVID(R) (ddC) and AZT interfere at the early phase of the replication cycle of HIV, the very last steps in the maturation process of the new viruses are inhibited by Invirase. Roche has requested an indication for the use of Invirase in combination with HIVID and/or AZT for the treatment of advanced HIV disease in selected patients (CD4 is less than or equal to 300 cells). A claim for use of Invirase as monotherapy for patients unable to tolerate other currently available therapies has also been requested. Roche plans to file additional new drug applications with health authorities worldwide in the coming weeks. New clinical data presented at the Fourth HIV Drug Resistance Workshop held in Sardinia, Italy, July 6-9, 1995 indicate that therapy with Invirase is unlikely to cause cross-resistance to most compounds in its class. The data also show that resistance to Invirase develops at a lower rate than seen with other AIDS drugs, even after prolonged treatment. In addition, these results suggest that a combination of Invirase and AZT may delay the resistance to either drug. The NDA filing is based on data from phase I/II studies carried out in Europe and in the U.S. (ACTG 229) and interim surrogate marker data from a North American phase III study. Data from these trials demonstrate that Invirase is well tolerated and shows activity against HIV as monotherapy and in combination with HIVID and/or AZT. The development of saquinavir Roche was the first to initiate research on proteinase inhibitors. Applying methods of rational drug design, Invirase was developed and synthesized for the first time in 1989. It was brought to preclinical development in late 1989, entry into man was in 1990 and dosing studies began in mid-1991. Based on results from phase I/II investigations, Roche began recruitment for a large phase III trial of AZT-pretreated patients in North America in February 1994. A second international phase III study enrolling patients without or with only limited previous treatment with AZT started in August 1994. Currently, there are approximately 3,600 patients enrolled in Invirase phase III trials. Additional studies to further define the potential of saquinavir are ongoing. A new, more bioavailable, oral formulation of saquinavir has been developed. This new formulation, suitable for clinical evaluation, will be used to confirm and expand on the promising data from a small phase I/II open-label clinical study utilizing saquinavir at higher dosages. This study indicates that saquinavir is well tolerated at higher levels. Based on these preliminary results, a phase I/II study with this more bioavailable formulation of saquinavir began in August 1995. A major challenge in the development of Invirase was the ability to manufacture sufficient amounts of drug. Due to the structural complexity of the compound, a lengthy and complex multiple-step synthesis is required; increasing the production capacities from laboratory to large-scale production was difficult. However, significant progress has been made in the manufacturing process, allowing Roche to initiate an international compassionate treatment program which makes Invirase available to people with AIDS who no longer benefit from other treatment alternatives. About Roche Hoffmann-La Roche Inc. of Nutley, N.J. is a research-based health care company that is a member of the Roche Group with headquarters in Basel, Switzerland. Roche is a leading health care company dedicated to the research, development and delivery of diagnostic tests, treatments and services for people with life-threatening diseases. CONTACT: Joy Schmitt of Roche, 201-562-2202
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